Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807164763571 Date of Approval: 09/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cognitive Impairment Trial
Official scientific title EFFECTS OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION AND BALANCE TRAINING ON FUNCTIONAL RECOVERY OF PEOPLE WITH CEREBROVASCULAR ACCIDENT AND ITS ASSOCIATION WITH COGNITIVE IMPAIRMENT
Brief summary describing the background and objectives of the trial The objectives of the trial is to determine the effects of proprioceptive neuromuscular facilitation (PNF) and task specific balance training (TSBT) on sub acute ischeamic stroke survivors with and without cognitive impairment. ischemic. Four outcome measures: Mini-mental State Examination, National Health Institute, Barthel Index and Bergs Balance will be used to measure cognitive impairment, stroke severity, activities of daily living and balance in the two groups. The study is going to be a non=randomized controlled clinicaltrial anticipating about 200 ischeamic stroke participants.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied crebrovascular accident, Cognitive impairment, stroke,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2018
Actual trial start date
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Nnamdi Azikiwe University Teaching Hospital Ethics Committee (Nauthec)
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised participants will be conviniently allocated to cognitive and non-cognitive impaured groups Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PNF and TSBT one hour per session three times per week one year muscle strenghtening, muscle stretching and balance training 50
Control Group PNF and TSBT one hour per session three times per week one year muscle strenghtening, muscle stretching and balance training 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Participants will be adults of between 30year and 65years of age because stroke is known to be common within that age group. ¿ Participants diagnosed as Ischemic stroke by consultants in medicine using the WHO criteria for stroke and MRI or CT scan radiological report from radiologists. ¿ Participants that were adjudged cognitive impaired and non-cognitive impaired using Minimental Stroke Scale Examination. ¿ Stroke duration of not more than 6 months ¿ No hemispheric discrimination ¿ Participants that were domiciled within Nnewi and its environs (Ichi, Amichi, Orifite, Utuh, Ozubulu, Nnobi) to enhance accessibility post discharge. ¿ Must have duly signed an informed consent document. ¿ Anybody having preexisting cognitive impairment, dementia (severe cognitive loss), Alzheimer disease, or head injury and diabetes. ¿ Anybody having history of repeat stroke. ¿ Anybody having any preexisting physical challenge that impaired participant¿s functional activities. ¿ Anybody having severe sensory loss, visual impairment and aphasia. . hemorrhagic stroke Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Nnamdi Azikiwe University Teaching Hospital Ethics Committee (NAUTHEC)
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Activities of daily living measured with barthel index the effect of intervention will be measured after every four months. That is baseline, four months, eight months and twelve months
Secondary Outcome Balance measurement using bergs balance scale the outcome of the intervention will be measured after four months- that is baseline, four months, eight months and twelve months
Secondary Outcome Cognitive impairment using mini-mental state examination the effect of intervention will be measured after every four months. That is baseline, four months, eight months and twelve months
Secondary Outcome Stroke severity using National health institute stroke scale the effect of intervention will be measured after every four months. That is baseline, four months, eight months and twelve months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Landmark Physiotherapi Services Anaedo Social Club Premises Nnewi 435101 Nigeria
Nnamdi Azikiwe University Teaching Hospital Nnewi Oil Onitsha Road Nnewi 435101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Department of Physiotherapy, Nnamdi Aziliwe University Teaching Hospital Nnewi Nnewi 435101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self funded Department of Physiotherapy, Nnamdi Aziliwe University Teaching Hospital Nnewi Nnewi 435101 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Okonkwo Uchenna Prosper Department of Physiotherapy, Nnamdi Aziliwe University Teaching Hospital Nnewi Nnewi 435101 Nigeria
Prof Goddy Okoye Department of Medical Rehabilitation, University of Nigeria Ebugu 400 Nigeria
Ibeneme Sam Department of Medical Rehabilitation, University of Nigeria Enugu 400 Nigeria
Ezema Charles Department of Medical Rehabilitation, University of Nigeria Enugu 400 Nigeria
Ebere Ihegihu Department of Physiotherapy, Nnamdi Aziliwe University Teaching Hospital Nnewi Nnewi 435101 Nigeria
Egwuonwu Victor Department of Medical Rehabilitation, Nnamdi Azikiwe University Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Uchenna Prosper Okonkwo drchiefprosper@gmail.com 08033611851 Department of Physiotherapy, NAUTH
City Postal code Country Position/Affiliation
NNewi 435101 Nigeria Assistant Director of Physiotherapy Swevices
Role Name Email Phone Street address
Public Enquiries Uchenna Prosper Okonkwo drchiefprosper@gmail.com 08033611851 Department of Physiotherapy, NAUTH
City Postal code Country Position/Affiliation
NNewi 435101 Nigeria Assistant Director of Physiotherapy Swevices
Role Name Email Phone Street address
Scientific Enquiries Afamefuna Victor Egwuonwu vaegwuonwu@unizik.edu.ng 08037791461 Department of Medical Rehabilitation, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
NNewi 435101 Nigeria Lecturer 1
REPORTING
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